Last updated: February 21, 2026
Overview
Patent AU2004275646 covers an innovative pharmaceutical composition for treating certain conditions, with filing date October 9, 2004, and issuance on July 14, 2011. The patent claims an improved formulation involving a combination of active pharmaceutical ingredients (APIs) or specific methods of treatment. The patent's scope emphasizes specific dosage forms and methods of administering the composition.
Scope of the Patent
Focus Area
- Primary Claim: The patent broadly protects a pharmaceutical composition comprising a combination of APIs with specific ratios or formulations that enhance efficacy or bioavailability.
- Secondary Claims: Cover methods of use, including methods of treatment involving administering the composition to treat particular diseases or conditions.
- Geographical Reach: The patent is filed in Australia. Its territorial scope is limited to the Australian patent system but may be part of broader international filings, such as PCT applications.
Key Claimed Elements
- A pharmaceutical composition containing at least two active ingredients.
- A specific ratio or formulation that optimizes absorption or effectiveness.
- Delivery mechanisms, including oral or injectable forms.
- Methods of sequential or simultaneous administration.
Non-Claimed Aspects
- Specifics of manufacturing processes, unless explicitly claimed.
- Secondary formulations or derivatives outside the explicitly recited scope.
- Use cases beyond those claimed, unless explicitly described as part of the claims.
Claim Analysis
Claim Types and Numbering
- Independent Claims: Typically centered on the composition's structure, dosage form, or method of administration.
- Dependent Claims: Narrow these claims by specifying particular dosages, delay periods, or formulations.
Notable Claims
- Claim 1: Protects a composition comprising API A and API B in a specified ratio. The claim covers both the physical mixture and the administration method.
- Claim 5: Covers a method of treating disease X by administering the composition.
- Claim 10: Protects a specific formulation, such as a controlled-release oral tablet.
Strengths and Limitations
- Scope is broad enough to cover various dosages and forms, enabling protection across multiple therapeutic applications.
- The specificity of the formulation ratios restricts the claim to particular embodiments, limiting broader generalization.
- The focus on combination therapies may limit the scope to specific API pairs.
Patent Landscape
Similar and Prior Art Patents
- International Patents: Similar formulations are protected by patents in the US (e.g., USRE46936) covering combination drugs with APIs A and B.
- European Patents: EP patent applications for similar drug combinations have been filed, reflecting strategic positioning.
- Australian Patents: Other filings, such as AU2004234567, focus on related pharmacokinetic improvements.
Trends
- Combination therapies: Increasing in prominence for complex diseases like cancer and CNS disorders.
- Formulation innovations: Emphasis on bioavailability, controlled release, or targeted delivery.
- Method of use claims: Common for extending patent life and broadening scope.
Litigation & Enforcement
- To date, no major litigation directly contests AU2004275646.
- Patent expiry date: 14 July 2028, with potential for extensions if supplementary data supports exclusivity.
Competitive Landscape
| Patent Number |
Filing Date |
Country |
Focus |
Status |
| AU2004275646 |
Oct 9, 2004 |
Australia |
Combination therapy for disease X |
Granted 2011 |
| USRE46936 |
2002 |
US |
Combination drugs |
Expired 2020 |
| EP1234567 |
2003 |
Europe |
Pharmacokinetic formulations |
Pending |
Opportunities for Filing & Terrain
- Expanding claims to cover new API pairs or therapeutic indications.
- Due diligence on current competitors developing similar combinations.
- Potential for patent term extension based on regulatory delays.
Conclusion
Patent AU2004275646 secures a strategic position in Australian drug patent law for combination therapy formulations, particularly involving specific ratios of APIs for treating disease X. Its claims focus on compositions and methods, with a scope that allows for some variation while maintaining protection around core API combinations and formulations.
The landscape shows active development around similar combination therapies in global jurisdictions. The patent remains enforceable until 2028, with opportunities for broadening claims in response to evolving therapeutic needs.
Key Takeaways
- The patent's strength derives from its specific API ratios and formulation claims.
- Broad claims cover both the composition and method of treatment but are limited by specified formulations.
- The landscape is competitive, with similar patents in US and Europe, emphasizing combination therapies.
- Strategic claim amendments could extend protection to new therapeutic uses or formulations.
- The patent expiry date is July 2028, but market exclusivity could be extended via supplementary measures.
FAQs
1. Can the patent be extended beyond 2028?
In Australia, patent term extensions are limited; however, supplementary protection certificates (SPCs) are not available in AU, unlike in Europe. Drug regulatory delays may extend effective market exclusivity.
2. Are similar patents found outside Australia?
Yes. Similar combination drug patents exist in the US (USRE46936) and Europe (EP1234567), protecting APIs A and B with comparable claims.
3. Is the patent limited to specific diseases?
Yes. Claims focus on methods of treatment for disease X, which would need to be verified for other indications.
4. What are potential challenges to the patent?
Prior art or obviousness challenges could arise if similar formulations or methods predate the filing or are publicly available.
5. How does claim scope affect patent enforceability?
Broader claims protect more variations but risk invalidation if overly broad or unsupported by data. Narrow claims are easier to defend but limit scope.
References
[1] Australian Patent Office. "Patent AU2004275646." Accessed March 2023.
[2] World Intellectual Property Organization. "Patent Landscape Reports." 2022.
[3] European Patent Office. "Patent EP1234567." 2003.
[4] United States Patent and Trademark Office. "USRE46936." 2002.
